(238 days)
No
The document describes an "ECG detection algorithm" and "analysis algorithm" for identifying arrhythmias, but does not explicitly mention or provide details about the use of AI or ML techniques. The performance testing is based on established standards for cardiac rhythm algorithms (ANSI/AAMI EC57), which do not inherently require AI/ML.
No
The device is described as a monitoring product used to identify non-lethal arrhythmias and collect ECG information. It supports diagnosis and monitoring of conditions but does not provide treatment or direct therapy.
Yes
The device is intended for "identifying non-lethal arrhythmias" and provides "continuous external electrocardiogram (ECG) information to support Holter Monitoring, Extended Holter Monitoring, and Outpatient Cardiac Telemetry (OCT)". It is used for "patients who experience transient symptoms that may suggest cardiac arrhythmia" and analyzes ECG data to identify events like "Ventricular Bigeminy" and "Supraventricular Couplet". These functions directly relate to diagnosing medical conditions.
No
The device description explicitly states it is a "body worn monitoring product that is designed with a disposable adhesive 7L Patch and reusable 7L Sensor." It also mentions a "SmartCardia Phone" and a "medical grade mains powered charger." These are all hardware components, indicating it is not a software-only device.
Based on the provided information, the SmartCardia 7L Platform is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- SmartCardia 7L Platform Function: The SmartCardia 7L Platform is a body-worn device that directly measures and records electrical activity of the heart (ECG) from the patient's skin. It analyzes this physiological signal to identify arrhythmias.
- Lack of Specimen Analysis: The device does not involve the analysis of any biological specimens taken from the body. It is a direct physiological monitoring device.
Therefore, the SmartCardia 7L Platform falls under the category of a physiological monitoring device, specifically for cardiac rhythm, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SmartCardia 7L Platform is a prescribed device used for the purpose of identifying non-lethal arrhythmias. The SmartCardia 7L Platform is intended for continuous external electrocardiogram (ECG) information to support Holter Monitoring, Extended Holter Monitoring, and Outpatient Cardiac Telemetry (OCT) commonly called Mobile Cardiac Telemetry (MCT) monitoring.
The SmartCardia 7L Platform is intended for:
-
Patients who experience transient symptoms that may suggest cardiac arrhythmia.
-
Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation).
-
Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c)
dyspnea (shortness of breath).
-
Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring.
-
ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports Measurements include: electrocardiogram (ECG signal), R-R interval, Heart Rate. Notification alerts can be set for one or more of these measures.
The SmartCardia 7L Platform is indicated for use on patients who are 18 years of age or older to provide monitoring of physiological information. It is intended for use in a physician office, outpatient facility, or in the patient's home.
SmartCardia 7L Platform contraindications:
-
The SmartCardia 7L Platform is contraindicated for use for detection of hemodynamically unstable or life-threatening arrhythmias or cardiac events requiring urgent medical response. It is not intended for monitoring patients during cardiac rehabilitation outside of healthcare facilities.
-
The SmartCardia 7L Platform is contraindicated for use during external defibrillation.
Product codes (comma separated list FDA assigned to the subject device)
QYX, DSI, DRG
Device Description
The SmartCardia 7L Platform MCT is a body worn monitoring product that is designed with a disposable adhesive 7L Patch and reusable 7L Sensor. It is designed to be worn by the patient for up to 14 days. If longer monitoring is necessary, the 7L Patch is removed from the body, the 7L Sensor is removed from the worn 7L Patch which is discarded. The 7L Sensor is inserted into a new 7L Patch and the new assembly is placed on the patient for monitoring to continue.
The 7L Sensor/7L Patch assembly communicates to the SmartCardia Phone via Bluetooth technology and shows the patient's heart rate and ECG on its display and allows the patient to input symptoms (Mark Event) which are shown in the patient record. The SmartCardia Phone has a medical grade mains powered charger and uses its cellular technology to act as a gateway to the SmartCardia Cloud Service provided by Amazon Web Services. The SmartCardia Phone is pre-configured by SmartCardia and placed in a kiosk mode. Data stored in the SmartCardia cloud can be viewed in the SmartCardia Web Browser application by a clinician or healthcare provider. The SmartCardia 7L Platform incorporates three modes of monitoring:
- Holter Monitoring (up to 48 hours) and Extended Holter Monitoring (>48 hours and up to 14 days),
- Event Monitoring (up to 48 hours, and >48 hours up to 14 days)
- Cardiac Outpatient Telemetry (OCT) commonly called Mobile Cardiac Telemetry (MCT) (>48 hours up to 30 days when changing the 7L Patch)
During any of the selected modes, a clinician or healthcare provider can use the SmartCardia Web Browser to view the continuously streaming patient's ECG.
The SmartCardia 7L Platform provides alarm notifications for heart rate and atrial fibrillation. As stated in the Intended Use statement, the system is contraindicated for use in a critical care setting where an immediate response to life threatening conditions such as lethal arrhythmias is required. There are no alarm signals presented to the clinician for conditions other than heart rate and atrial fibrillation. The SmartCardia 7L Platform performs retrospective analysis and identifies events which it shows the clinician when they are reviewing historical data. The clinician must then review these events and determine if they are indeed valid and should be included in a physician's report. These events are things like 'Ventricular Bigeminy', 'Supraventricular Couplet', etc. A full list is included in the Clinician Instructions for Use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Physician office, outpatient facility, or in the patient's home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The ECG detection algorithm was tested per ANSI/AAMI EC57 standard for testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms. The SmartCardia 7L Platform does not claim ST analysis or measurements. Therefore, the sections of the EC57 standard relating to ST measurement is not applicable. Because of the nature of the SmartCardia 7L Platform as a body worn sensor and patch device with the electrodes in close proximity to each other, and not utilizing ECG lead wires such as a traditional ECG device, SmartCardia developed a protocol and database for evaluating the analysis algorithm. The results show that the SmartCardia 7L Platform algorithm detection and reported results for the stated output arrhythmia were satisfactory and met industry norms.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Bench Performance Testing Summary: The SmartCardia 7L Platform was tested for compliance with FDA Guidance "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm" released October 28, 2003.
Additional non- clinical bench performance testing was done per the following:
• Basic Safety and Essential Performance per IEC 60601-1
• Electromagnetic Compatibility per IEC 60601-2
• Wireless Coexistence testing per FDA Guidance document "Radio Frequency Wireless Technology in Medical Devices, August 14, 2013", and exposure to RFID devices per AIM 7351731.
• Wireless Coexisting testing per ANSI C63.27: 2017
• ECG Monitoring for Ambulatory ECG devices per IEC 60601-2-47
• Life Cycle testing per IEC 60601-11 Home Healthcare
• ECG electrode testing per ANSI/AAMI EC12
• Cleaning and disinfection methods as defined by SmartCardia SA
• ECG Waveform Quality and Wearability
• Effects of Sensor Positioning on ECG Performance
• DVR-66 SCDB ECG Test Results (algorithm testing and reporting) per EC57
Objective(s) of the Test(s): To test the claimed ranges of measurement provided in the specification and labeling that support the intended use and three monitoring modes of operation: Holter and Extended Holter (Ambulatory electrocardiographic monitoring, Event Monitoring).
Test Methods: Bench testing was performed on an end-to-end system using electronic patient simulators and/or electronic test equipment (signal generators, etc.). This was performed per the applicable standards using production equivalent units.
Pass/Fail Criteria: Pass criteria is compliance with the claimed range and precision provided in the labeling for the SmartCardia 7L Platform. Deviations from the recognized standard criteria are identified in the applicable test report.
Results Summary: Testing showed that the SmartCardia 7L Platform met the pass/fail criteria established by the appropriate standards. The SmartCardia 7L Platform is contraindicated for use during defibrillation and is visibly labeled to indicate removal during defibrillation. Defibrillator protection testing was performed to ensure there was not excessive energy shunted away from the patient during defibrillation.
To verify the reproduction of the ECG and ensure that there are not significant morphological changes that could impact the measurements and/or classifications, SmartCardia SA performed verification testing using a standard 12 lead ECG machine and comparing the morphology and ECG characteristics. The result of this testing is included in the document, DVR-67-01 ECG Waveform Quality and Wearability Report is included in this section.
The ECG detection algorithm was tested per ANSI/AAMI EC57 standard for testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms. The SmartCardia 7L Platform does not claim ST analysis or measurements. Therefore, the sections of the EC57 standard relating to ST measurement is not applicable. Because of the nature of the SmartCardia 7L Platform as a body worn sensor and patch device with the electrodes in close proximity to each other, and not utilizing ECG lead wires such as a traditional ECG device, SmartCardia developed a protocol and database for evaluating the analysis algorithm. The results show that the SmartCardia 7L Platform algorithm detection and reported results for the stated output arrhythmia were satisfactory and met industry norms.
Discussion/Conclusion: Based on a review of the test results and a comparison to the predicate devices characteristics and known specifications, the results show that the SmartCardia 7L Platform is substantially equivalent to the predicate and reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 31, 2024
SmartCardia SA % Robert Steurer Consultant Steurer Consulting Group LLC 800 Blue Quail Rd Keller, Texas 76248
Re: K240653
Trade/Device Name: SmartCardia 7L Platform Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: QYX, DSI, DRG Dated: October 1, 2024 Received: October 2, 2024
Dear Robert Steurer:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Jennifer W. Shih -S
Jennifer Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240653
Device Name SmartCardia 7L Platform
Indications for Use (Describe)
The SmartCardia 7L Platform is a prescribed device used for the purpose of identifying non-lethal arrhythmias. The SmartCardia 7L Platform is intended for continuous external electrocardiogram (ECG) information to support Holter Monitoring, Extended Holter Monitoring, and Outpatient Cardiac Telemetry (OCT) commonly called Mobile Cardiac Telemetry (MCT) monitoring.
The SmartCardia 7L Platform is intended for:
-
Patients who experience transient symptoms that may suggest cardiac arrhythmia.
-
Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation).
-
Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c)
dyspnea (shortness of breath).
-
Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring.
-
ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports Measurements include: electrocardiogram (ECG signal), R-R interval, Heart Rate. Notification alerts can be set for one or more of these measures.
The SmartCardia 7L Platform is indicated for use on patients who are 18 years of age or older to provide monitoring of physiological information. It is intended for use in a physician office, outpatient facility, or in the patient's home.
SmartCardia 7L Platform contraindications:
-
The SmartCardia 7L Platform is contraindicated for use for detection of hemodynamically unstable or life-threatening arrhythmias or cardiac events requiring urgent medical response. It is not intended for monitoring patients during cardiac rehabilitation outside of healthcare facilities.
-
The SmartCardia 7L Platform is contraindicated for use during external defibrillation.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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5
| Date Prepared: | October 28, 2024 |
|---|---|
| Submitter: | SmartCardia SA |
| EPFL Innovation Park | |
| Building C | |
| 1015, Lausanne, Switzerland | |
| Srinivasan Murali | |
| SmartCardia SA | |
| Phone: +41 7887 50864 | |
| Fax: N/A | |
| Email: srinivasan.murali@smartcardia.com | |
| Application Correspondent: | Robert Steurer |
| Principal Consultant | |
| Steurer Consulting Group | |
| 800 Blue Quail Rd. | |
| Keller, TX 76248 | |
| steurerbob@gmail.com | |
| +1 (425) 358-1072 | |
| Manufacturing Site: | SmartCardia SA |
| EPFL Innovation Park | |
| Building C | |
| 1015, Lausanne, Switzerland | |
| Common Name: | SmartCardia 7L Platform |
| Classification Name: | Arrhythmia detector and alarm (including ST-segment measurement |
| and alarm) | |
| Device Class: | Class II |
| Primary Classification | |
| Regulation: | 21 CFR 870.1025 |
| Primary Product Code: | QYX |
| Secondary Codes: | DSI,DRG |
| Primary Predicate Device: | InfoBionics MoMe Kardia, K160004 |
| Reference Predicate Device: | SmartCardia 7L Platform, K231276 |
| Device Description: | |
| The SmartCardia 7L Platform MCT is a body worn monitoring product that is designed with a disposable adhesive 7L Patch and reusable 7L Sensor. It is designed to be worn by the patient for up to 14 days. If longer monitoring is necessary, the 7L Patch is removed from the body, the 7L Sensor is removed from the worn 7L Patch which is discarded. The 7L Sensor is inserted into a new 7L Patch and the new assembly is placed on the patient for monitoring to continue. |
The 7L Sensor/7L Patch assembly communicates to the SmartCardia Phone via Bluetooth technology and shows the patient's heart rate and ECG on its display and allows the patient to input symptoms (Mark Event) which are shown in the patient record. The SmartCardia Phone has a medical grade mains powered charger and uses its cellular technology to act as a gateway to the SmartCardia Cloud Service provided by Amazon Web Services. The SmartCardia Phone is pre-configured by SmartCardia and placed in a kiosk mode. Data stored in the SmartCardia cloud can be viewed in the SmartCardia Web Browser application by a clinician or healthcare provider. The SmartCardia 7L Platform incorporates three modes of monitoring:
- Holter Monitoring (up to 48 hours) and Extended Holter Monitoring (>48 hours and up to 14 days),
- Event Monitoring (up to 48 hours, and >48 hours up to 14 days)
- Cardiac Outpatient Telemetry (OCT) commonly called Mobile Cardiac Telemetry (MCT) (>48 hours up to 30 days when changing the 7L Patch)
During any of the selected modes, a clinician or healthcare provider can use the SmartCardia Web Browser to view the continuously streaming patient's ECG.
The SmartCardia 7L Platform provides alarm notifications for heart rate and atrial fibrillation. As stated in the Intended Use statement, the system is contraindicated for use in a critical care setting where an immediate response to life threatening conditions such as lethal arrhythmias is required. There are no alarm signals presented to the clinician for conditions other than heart rate and atrial fibrillation. The SmartCardia 7L Platform performs retrospective analysis and identifies events which it shows the clinician when they are reviewing historical data. The clinician must then review these events and determine if they are indeed valid and should be included in a physician's report. These events are things like "Ventricular Bigeminy', 'Supraventricular Couplet', etc. A full list is included in the Clinician Instructions for Use. | |
| Intended Use / Indications for Use: | |
| The SmartCardia 7L Platform is a prescribed device used for the purpose of identifying non-lethal arrhythmias. The SmartCardia 7L Platform is intended for continuous external electrocardiogram (ECG) information to support Holter Monitoring, Extended Holter Monitoring, and Outpatient Cardiac Telemetry (OCT) commonly called Mobile Cardiac Telemetry (MCT) monitoring.
The SmartCardia 7L Platform is intended for:
- Patients who experience transient symptoms that may suggest cardiac arrhythmia.
- Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation).
- Patients with symptoms that may be due to cardiac arrhythmias. These | |
6
7
| Summary of Substantial Equivalence: | Substantial Equivalence – Predicate Device: InfoBionics MoMe Kardia, K160064 |
|---|---|
| Intended Use: | |
| MoMe Kardia is intended to be used for: Patients who experience transient symptoms that may suggest cardiac arrhythmia.Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath)Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring.ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports. | |
| MoMe® Kardia is contraindicated for: | |
| MoMe® Kardia is contraindicated for those patients requiring attended, in-hospital monitoring for life threatening arrhythmias. | |
| Note: MoMe® Kardia does not provide interpretive statements. Interpretation and diagnosis is the responsibility of a physician. |
may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath).
-
Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring.
-
ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports. Measurements include: electrocardiogram (ECG signal), R-R interval, Heart Rate. Notification alerts can be set for one or more of these measures.
The SmartCardia 7L Platform is indicated for use on patients who are 18 years of age or older to provide monitoring of physiological information. It is intended for use in a physician office, outpatient facility, or in the patient's home.
SmartCardia 7L Platform contraindications:
-
The SmartCardia 7L Platform is contraindicated for use for detection or notification of hemodynamically unstable or life-threatening arrhythmias or cardiac events requiring urgent medical response. It is not intended for monitoring patients during cardiac rehabilitation outside of healthcare facilities.
-
The SmartCardia 7L Platform is contraindicated for use during external defibrillation.
8
| | Substantial Equivalence - Intended Use Comparison Statement:
The indications for use of the InfoBionics MoMe Kardia predicate device and
the SmartCardia 7L Platform MCT device are substantially equivalent. The
SmartCardia 7L Platform MCT adds Outpatient Cardiac Telemetry, commonly
called Mobile Cardiac Telemetry as a mode of operation in its indications for
use. The user population and environment of operation are the same. The
product code is changed to the newly released QYX. The regulation number
and special controls are the same as the predicate product code DSI, 870.1025. |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The subject device SmartCardia 7L Platform MCT is an update to the Reference
Predicate Device SmartCardia 7L Web Browser software. The data acquisition
uses the same technology as the predicate device. |
| | 1) The same SmartCardia 7L Sensor and 7L Patch communicate wirelessly to
the same SmartCardia Phone that transmits the data to the same
SmartCardia 7L cloud based server for storage and further analysis. |
| | 2) The SmartCardia 7L Platform MCT has three modes of operation for
Holter, Extended Holter and Event monitoring. All of these modes of
operation provide continuous streaming of the ECG for viewing by a clinician
or qualified cardiac technician in the same manner as the Predicate
Device. The subject SmartCardia 7L Platform MCT updates the platform to
include Outpatient Cardiac Telemetry (OCT) which is commonly called
Mobile Cardiac Telemetry (MCT) as a mode of operation. The use of the
SmartCardia 7L Platform MCT for Mobile Cardiac Telemetry is manged by
SmartCardia through its supplier control requirements, personnel access
limitations, monitoring settings, and timely notifications by an independent
diagnostic testing facility (IDTF) personnel. |
| Non-Clinical Bench
Performance Testing
Summary: | The SmartCardia 7L Platform was tested for compliance with FDA
Guidance "Class II Special Controls Guidance Document: Arrhythmia
Detector and Alarm" released October 28, 2003. |
| | Additional non- clinical bench performance testing was done per
the following: |
| | • Basic Safety and Essential Performance per IEC 60601-1
• Electromagnetic Compatibility per IEC 60601-2
• Wireless Coexistence testing per FDA Guidance document "Radio
Frequency Wireless Technology in Medical Devices, August 14, 2013",
and exposure to RFID devices per AIM 7351731.
• Wireless Coexisting testing per ANSI C63.27: 2017
• ECG Monitoring for Ambulatory ECG devices per IEC 60601-2-47
• Life Cycle testing per IEC 60601-11 Home Healthcare
• ECG electrode testing per ANSI/AAMI EC12
• Cleaning and disinfection methods as defined by SmartCardia SA
• ECG Waveform Quality and Wearability
• Effects of Sensor Positioning on ECG Performance
• DVR-66 SCDB ECG Test Results (algorithm testing and reporting) per
EC57 |
| | Objective(s) of the Test(s):
To test the claimed ranges of measurement provided in the
specification and labeling that support the intended use and three
monitoring modes of operation: Holter and Extended Holter
(Ambulatory electrocardiographic monitoring, Event Monitoring). |
9
Test Methods
Bench testing was performed on an end-to-end system using electronic patient simulators and/or electronic test equipment (signal generators, etc.). This was performed per the applicable standards using production equivalent units.
Pass/Fail Criteria
Pass criteria is compliance with the claimed range and precision provided in the labeling for the SmartCardia 7L Platform. Deviations from the recognized standard criteria are identified in the applicable test report.
Results Summary
Testing showed that the SmartCardia 7L Platform met the pass/fail criteria established by the appropriate standards. The SmartCardia 7L Platform is contraindicated for use during defibrillation and is visibly labeled to indicate removal during defibrillation. Defibrillator protection testing was performed to ensure there was not excessive energy shunted away from the patient during defibrillation.
To verify the reproduction of the ECG and ensure that there are not significant morphological changes that could impact the
measurements and/or classifications, SmartCardia SA performed verification testing using a standard 12 lead ECG machine and comparing the morphology and ECG characteristics. The result of this testing is included in the document, DVR-67-01 ECG Waveform Quality and Wearability Report is included in this section.
The ECG detection algorithm was tested per ANSI/AAMI EC57 standard for testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms. The SmartCardia 7L Platform does not claim ST analysis or measurements. Therefore, the sections of the EC57 standard relating to ST measurement is not applicable. Because of the nature of the SmartCardia 7L Platform as a body worn sensor and patch device with the electrodes in close proximity to each other, and not utilizing ECG lead wires such as a traditional ECG device, SmartCardia developed a protocol and database for evaluating the analysis algorithm. The results show that the SmartCardia 7L Platform algorithm detection and reported results for the stated output arrhythmia were satisfactory and met industry norms.
Discussion/Conclusion: Based on a review of the test results and a comparison to the predicate devices characteristics and known specifications, the results show that the SmartCardia 7L Platform is substantially equivalent to the predicate and reference devices.